Companion Diagnostics Market (2030) Size, Share And Trend Analysis Report By Region And Segmentation Forecasts

Companion Diagnostics Market Size and Overview

The companion diagnostics market revenue is estimated to be reach $6 billion by 2030, driven by the companion diagnostics for oncology market segment. The introduction of personalized medicine has brought about a paradigm shift within the healthcare sector. Over the years, many cases have been identified where conventional treatment options have failed to demonstrate any therapeutic benefit. It is estimated that nearly 50% of prescribed drugs / therapies fail to show adequate clinical benefits. In fact, adverse drug-related reactions / side effects are reported to be the fourth leading cause of death in the US.  To mitigate challenges associated with adverse drug reactions, there are multiple therapeutic products in the market, and many more under development, which have been tailored to effectively treat disease with unique molecular / genetic signatures. 

Personalized therapies demand companion diagnostics to make physicians aware of patients’ unique genetic profiles, thereby, enabling them to make informed decisions. A study of nearly 200 unique pharmacological interventions, across 670 clinical trials, concluded that the likelihood of a lead compound passing through all the phases of clinical development and eventually getting approved is only 11%. The same study highlighted that correlating disease-specific biomarker data with therapeutic susceptibility and using this information to recruit patients for clinical research demonstrated a six fold increase in trial success rates.  It is also worth highlighting that companion diagnostic guided drug development efforts have been estimated to help reduce clinical trial costs by almost 60%.  

Since the approval of the HercepTest™ (in 1998) for identifying patients for treatment with trastuzumab, over 50 companion diagnostics have been developed for various drugs. Further, several companies have also undertaken initiatives to develop biomarker-based therapeutics for other disease indications, such as infectious diseases, neurological disorders and metabolic disorders.  Industry stakeholders are forging strategic alliances with diagnostic developers to develop diagnostic solutions for a diverse array of drugs / therapies. Such initiatives are focused on improving clinical trial success rates, and subsequently optimizing R&D expenditure in the pharmaceutical industry.

Key Companies in Companion Diagnostics Market 

Examples of key companion diagnostics companies engaged in companion diagnostics market (which have also been profiled in this market report; the complete list of companion diagnostics companies is available in the full report) include Roche, Agilent Technologies, Abbott, QIAGEN, Myriad Genetics and Foundation Medicine. This market report includes an easily searchable excel database of all the companion diagnostics companies providing companion diagnostics, worldwide.

Recent Developments in Companion Diagnostics Market:

Several recent developments have taken place in the field of companion diagnostics market. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In March 2026, the FDA approved Agilent Technologies' PD-L1 IHC 22C3 pharmDx as a companion diagnostic to select esophageal or gastroesophageal junction carcinoma patients suitable for Merck's KEYTRUDA.
• In January 2026, Guardant Health entered into a collaboration with Merck to develop companion diagnostics using Guardant Infinity platform, accelerating biomarker discovery, clinical trial enrollment, and real-world evidence generation for Merck's oncology program.
• In October 2025, Lunit collaborated with Agilent Technologies to develop AI-powered companion diagnostics, integrating Lunit's AI algorithms with Agilent's IHC assays for precise biomarker detection in cancer, enhancing drug development and patient stratification globally.
• In September 2025, Illumina partnered with pharma companies to expand companion diagnostic development on TruSight Oncology 500 ctDNA test for KRAS alterations, enabling tumor-agnostic genomic profiling to guide precision therapies across multiple cancer types across the globe.
• In September 2025, Predicine submitted first PMA module to FDA for PredicineCARE urine cfDNA NGS assay as companion diagnostic for bladder cancer, providing noninvasive multi-cancer detection to support precision treatment decisions in urologic oncology.

Companion Diagnostics Market Trends and Scope

The “Companion Diagnostics Market (2nd Edition), 2019-2030” market report features an extensive study of the current market landscape, market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunities of the companion diagnostics market. The market research report features an in-depth analysis, highlighting the capabilities of the various stakeholders in companion diagnostics market. In addition to other elements, the market research report includes:

• A detailed assessment of the current market landscape of companies offering companion diagnostics, including information on their geographical location, corresponding drug(s) / drug class, affiliated biomarker, assay technique involved (in situ hybridization (ISH), immunohistochemistry  (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others), therapeutic area (oncological disorders, infectious diseases, metabolic disorders, neurological disorders, inflammatory disorders and others) and the type of sample required (tumor tissue, blood, bone marrow and others).
• Detailed profiles of developers of companion diagnostics (shortlisted on the basis of the strength of product portfolio), featuring an overview of the company, its financial information (if available), a detailed description of companion diagnostics available / under development and recent collaborations. In addition, each profile includes a list of the likely strategies that may be adopted by these players to support future growth.
• A detailed brand positioning analysis of leading industry players (shortlisted on the basis of strength of product portfolio), highlighting the current perceptions regarding their proprietary brands, taking into consideration several relevant aspects, such as strength of product portfolio, geographical presence / reach, recent collaborations, diversity in therapeutic focus and overall market position of each company.
• An analysis of the partnerships and collaborations pertaining to companion diagnostics, featuring a comprehensive set of analyses based on various parameters, such as the type of partnership, affiliated biomarkers, therapeutic areas and the most active players.
• A comparative analysis of the needs of different stakeholders (drug developers, diagnostic developers, testing laboratories, physicians, payers and patients) involved in companion diagnostics market.
• A discussion on various steps of the development operations, namely research and development, clinical assessment of the product, manufacturing and assembly, payer negotiation and marketing / sales activities, of a companion diagnostic and the cost requirements across each of the aforementioned stages.
• A comprehensive analysis of completed, ongoing and planned clinical trials featuring the key biomarkers across different type of therapies and cancer indications. The analysis highlights the key trends associated with these clinical studies across various parameters, such as trial start year, trial status, phase of development, key indications, type of therapy, biomarkers evaluated, enrolled patient population and regional distribution of trials.

The key objective of companion diagnostics market report is to provide a detailed market analysis in order to estimate the existing market size, market share, market growth, market trends, market value, market forecast, market outlook, statistics and future opportunity for companion diagnostics market during the forecast period. Based on multiple parameters, such as the disease incidence, adoption of companion diagnostic tests and the likely prices, we have provided informed estimates on the evolution of the market for the forecast period 2019-2030. The market report also features the likely distribution of the current and forecasted opportunity across [A] different therapeutic areas (oncological disorders (breast cancer, colorectal cancer, leukemia, lymphoma, melanoma, non-small cell lung cancer and ovarian cancer) and non-oncological disorders (Alzheimer’s disease and HIV/AIDs), [B] important assay techniques (in situ hybridization (ISH), immune histochemistry (IHC), next generation sequencing (NGS), polymerase chain reaction (PCR) and others) and [C] key geographical regions (US, EU5, Japan, China and Australia). In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.  

The opinions and insights presented in this market research report were also influenced by discussions conducted with stakeholders in companion diagnostics market. All actual figures have been sourced and analyzed from publicly available information forums. Financial figures mentioned in this market report are in USD, unless otherwise specified.